Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20260101 - 20261231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 26938941 |
US |
2 | |
Product container seal issue, Drug dose omission by device, Product use in unapproved indication, Product administered at inappropriate site, Device malfunction, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), DUPILUMAB, AMLODIPINE BESYLATE, |
||||
| 102 | 26938951 |
US |
74 | 2 |
Sinus disorder, Iron deficiency, Fatigue, Bone pain, Arthralgia, Heart rate increased, Product dose omission issue, Device leakage, Drug dose omission by device, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, MAGNESIUM, MIRABEGRON, PHYTONADIONE, |
||||
| 103 | 26938958 |
US |
79 | 1 |
Therapy interrupted, Intentional dose omission, Product use complaint, Needle issue, Needle issue, Drug dose omission by device, Drug ineffective, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 104 | 26939054 |
US |
82 | 2 |
Device delivery system issue, Device failure, Drug dose omission by device, |
||||
ABALOPARATIDE, |
||||
| 105 | 26939165 |
US |
2 | |
Therapy interrupted, Drug dose omission by device, Device failure, Device issue, Device failure, Product dose omission issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, PIROXICAM, |
||||
| 106 | 26939265 |
US |
2 | |
Dermal cyst, Balance disorder, Musculoskeletal stiffness, Nausea, Injection site erythema, Contusion, Drug dose omission by device, Device malfunction, Needle issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ERGOCALCIFEROL, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, AMLODIPINE, BIOTIN, BUPROPION HYDROCHLORIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FOLIC ACID, HYDROXYCHLOROQUINE, METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 107 | 26939466 |
US |
95 | 2 |
Device defective, Drug dose omission by device, Product dose omission issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, VIBEGRON, |
||||
| 108 | 26939545 |
US |
66 | 2 |
Illness, Fatigue, Drug dose omission by device, Device breakage, Wrong technique in device usage process, |
||||
ABALOPARATIDE, |
||||
| 109 | 26939616 |
US |
74 | 2 |
Visual impairment, Drug dose omission by device, Device difficult to use, Inappropriate schedule of product administration, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 110 | 26939632 |
US |
65 | 2 |
Drug dose omission by device, Device defective, |
||||
ABALOPARATIDE, APREMILAST, |
||||
| 111 | 26939661 |
US |
||
Device physical property issue, Device defective, Drug dose omission by device, Product use complaint, Device breakage, |
||||
ABALOPARATIDE, ABALOPARATIDE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, LEVOTHYROXINE SODIUM, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, LOSARTAN POTASSIUM, LOSARTAN, |
||||
| 112 | 26939703 |
US |
62 | 2 |
Product contamination physical, Liquid product physical issue, Drug dose omission by device, |
||||
ABALOPARATIDE, |
||||
| 113 | 26939761 |
US |
43 | 1 |
Drug dose omission by device, Liquid product physical issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 114 | 26939895 |
US |
69 | 2 |
Injection site erythema, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 115 | 26939943 |
US |
65 | 1 |
Mental fatigue, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, |
||||
| 116 | 26931422 |
US |
15 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 117 | 26931790 |
GB |
55 | 1 |
Needle issue, Drug dose omission by device, |
||||
PEGVISOMANT, |
||||
| 118 | 26932722 |
US |
||
Device deployment issue, Drug dose omission by device, Condition aggravated, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 119 | 26932737 |
US |
22 | |
Asthma, Dyspnoea, Device delivery system issue, Wrong technique in product usage process, Drug dose omission by device, Device deposit issue, Prescription drug used without a prescription, |
||||
ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, |
||||
| 120 | 26933177 |
US |
2 | |
Device leakage, Drug dose omission by device, |
||||
| 121 | 26933180 |
US |
2 | |
Drug dose omission by device, Device malfunction, Device leakage, Device leakage, Product quality issue, |
||||
| 122 | 26934018 |
US |
2 | |
Device difficult to use, Injection site erythema, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 123 | 26934044 |
US |
44 | 1 |
Injection site bruising, Drug dose omission by device, Device difficult to use, Blood cholesterol increased, |
||||
EVOLOCUMAB, |
||||
| 124 | 26926863 |
EU |
68 | 1 |
Blood glucose increased, Drug dose omission by device, Device breakage, Device leakage, Device failure, |
||||
INSULIN ASPART INJECTION, INSULIN ASPART, |
||||
| 125 | 26927037 |
US |
71 | |
Drug dose omission by device, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, FUROSEMIDE, |
||||
| 126 | 26927409 |
US |
76 | |
Drug dose omission by device, Device delivery system issue, Off label use, |
||||
ALBUTEROL SULFATE, OXYGEN, 0XYGEN, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, MONTELUKAST SODIUM, LORATADINE, LORATADINE TABLET, FAMOTIDINE, AMLODIPINE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ATORVASTATIN CALCIUM, CLOPIDOGREL, CEPHALEXIN, DOXYCYCLINE, DOXYCYCLINE HYCLATE, |
||||
| 127 | 26927411 |
US |
90 | |
Wheezing, Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, |
||||
ALBUTEROL SULFATE, |
||||
| 128 | 26927415 |
US |
75 | |
Drug dose omission by device, Device malfunction, Wrong technique in product usage process performed in error, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 129 | 26927596 |
US |
25 | 2 |
Device defective, Device malfunction, Device leakage, Injection site erythema, Drug dose omission by device, |
||||
| 130 | 26928306 |
US |
2 | |
Accidental exposure to product, Blood glucose increased, Device leakage, Device malfunction, Drug dose omission by device, |
||||
INSULIN ASPART, |
||||
| 131 | 26928968 |
US |
15 | 2 |
Drug dose omission by device, Wrong technique in device usage process, |
||||
LONAPEGSOMATROPIN-TCGD, METHYLPHENIDATE HYDROCHLORIDE, LITHIUM, LITHIUM BROMATUM, LITHIUM, LITHIUM BROMATUM, HYDROXYZINE, |
||||
| 132 | 26929007 |
US |
73 | |
Wrong technique in device usage process, Drug dose omission by device, Wrong technique in product usage process performed in error, Prescription drug used without a prescription, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 133 | 26929986 |
US |
75 | 1 |
Device difficult to use, Product communication issue, Drug dose omission by device, Drug ineffective, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 134 | 26930875 |
US |
18 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 135 | 26930876 |
US |
||
Drug dose omission by device, Device breakage, Device leakage, |
||||
SOMATROPIN, |
||||
| 136 | 26930958 |
CO |
1 | |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 137 | 26930968 |
US |
12 | 1 |
Device malfunction, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 138 | 26930969 |
CO |
1 | |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 139 | 26930971 |
GB |
11 | 1 |
Device defective, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 140 | 26930972 |
US |
62 | 2 |
Drug dose omission by device, Device material issue, |
||||
SOMATROPIN, |
||||
| 141 | 26930973 |
US |
10 | 1 |
Drug dose omission by device, Device physical property issue, Device information output issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 142 | 26930978 |
EU |
12 | 2 |
Device mechanical issue, Device use issue, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 143 | 26930982 |
CO |
1 | |
Drug dose omission by device, Device information output issue, Device physical property issue, |
||||
SOMATROPIN, |
||||
| 144 | 26930985 |
US |
14 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 145 | 26921609 |
US |
||
Drug dose omission by device, Product contamination physical, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 146 | 26921958 |
US |
76 | 2 |
Device difficult to use, Drug dose omission by device, Gait disturbance, Incorrect disposal of product, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 147 | 26922112 |
US |
75 | 2 |
Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 148 | 26922323 |
US |
55 | 2 |
Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, Injection site pain, |
||||
ETANERCEPT, ETANERCEPT, |
||||
| 149 | 26923271 |
US |
65 | 1 |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, CARVEDILOL, |
||||
| 150 | 26923455 |
US |
63 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, Off label use, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 151 | 26923691 |
US |
82 | 1 |
Glaucoma, Wrong technique in product usage process, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, ORAL SEMAGLUTIDE, |
||||
| 152 | 26924463 |
CO |
1 | |
Nervousness, Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 153 | 26924607 |
US |
1 | 2 |
Drug dose omission by device, Device mechanical issue, Device information output issue, |
||||
SOMATROPIN, |
||||
| 154 | 26924609 |
CO |
1 | |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 155 | 26924610 |
US |
13 | 2 |
Drug dose omission by device, Device breakage, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 156 | 26924613 |
US |
1 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 157 | 26924618 |
US |
43 | 1 |
Device malfunction, Device leakage, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 158 | 26925090 |
US |
56 | 2 |
Device difficult to use, Accidental exposure to product, Drug dose omission by device, Device use error, Pain in extremity, Exposure via skin contact, |
||||
ERENUMAB-AOOE, |
||||
| 159 | 26925318 |
US |
2 | |
Lung neoplasm malignant, Device difficult to use, Incorrect disposal of product, Ill-defined disorder, Drug dose omission by device, Dyspnoea, Therapeutic product effect incomplete, |
||||
ERENUMAB-AOOE, INFLIXIMAB, RIMEGEPANT SULFATE, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE, |
||||
| 160 | 26925905 |
CO |
2 | |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 161 | 26926341 |
US |
78 | 2 |
Injection site bruising, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 162 | 26926396 |
US |
91 | 2 |
Drug dose omission by device, Device difficult to use, Accidental exposure to product, Exposure via skin contact, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 163 | 26926509 |
US |
80 | 2 |
Drug dose omission by device, Device difficult to use, Injection site indentation, |
||||
EVOLOCUMAB, ORAL SEMAGLUTIDE, |
||||
| 164 | 26914659 |
US |
73 | 1 |
Device difficult to use, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, |
||||
EVOLOCUMAB, |
||||
| 165 | 26914973 |
US |
2 | |
Drug dose omission by device, Device leakage, Weight decreased, Nervousness, Vomiting, |
||||
ORAL SEMAGLUTIDE, |
||||
| 166 | 26915019 |
US |
||
Device delivery system issue, Drug dose omission by device, Exposure via skin contact, Device delivery system issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 167 | 26915110 |
US |
2 | |
Syringe issue, Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 168 | 26915827 |
US |
65 | 2 |
Accidental exposure to product, Exposure via skin contact, Product administration error, Drug dose omission by device, |
||||
DENOSUMAB, |
||||
| 169 | 26915957 |
US |
57 | 2 |
Drug dose omission by device, Device difficult to use, Tremor, Trigger finger, |
||||
ETANERCEPT, |
||||
| 170 | 26916082 |
US |
52 | |
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, Device malfunction, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 171 | 26916504 |
US |
2 | |
Cerebrovascular accident, Atrial fibrillation, Drug dose omission by device, Device difficult to use, |
||||
ETANERCEPT, |
||||
| 172 | 26917094 |
US |
||
Device mechanical issue, Drug dose omission by device, Device delivery system issue, |
||||
GUSELKUMAB, |
||||
| 173 | 26917195 |
EU |
57 | 2 |
Device failure, Drug dose omission by device, Expired device used, |
||||
EPINEPHRINE, |
||||
| 174 | 26917458 |
US |
72 | |
Loss of personal independence in daily activities, Drug dose omission by device, Wrong technique in product usage process performed in error, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, PREGABALIN, RIVAROXABAN, LISINOPRIL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE INJECTION, |
||||
| 175 | 26917547 |
CO |
2 | |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 176 | 26917557 |
US |
12 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 177 | 26917558 |
CO |
1 | |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 178 | 26917566 |
GB |
76 | 1 |
Drug dose omission by device, Device malfunction, |
||||
SOMATROPIN, |
||||
| 179 | 26917567 |
CO |
2 | |
Drug dose omission by device, Device information output issue, Device defective, |
||||
SOMATROPIN, |
||||
| 180 | 26917588 |
CO |
1 | |
Drug dose omission by device, Device mechanical issue, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 181 | 26918284 |
US |
35 | 2 |
Drug dose omission by device, Product packaging quantity issue, |
||||
EPINEPHRINE, ADRENALINUM, |
||||
| 182 | 26918798 |
EU |
39 | 2 |
Device operational issue, Device occlusion, Drug dose omission by device, Incorrect dose administered by device, |
||||
PEGFILGRASTIM-APGF, |
||||
| 183 | 26918804 |
JP |
1 | |
Device use error, Device malfunction, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 184 | 26919017 |
US |
||
Drug dose omission by device, No adverse event, |
||||
GLUCAGON, |
||||
| 185 | 26919075 |
US |
20 | 2 |
Drug dose omission by device, Device difficult to use, Migraine, Injection site pain, |
||||
ERENUMAB-AOOE, ONABOTULINUMTOXINA, RIMEGEPANT SULFATE, |
||||
| 186 | 26920932 |
CO |
2 | |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 187 | 26920970 |
US |
85 | 1 |
Drug dose omission by device, Headache, Device difficult to use, |
||||
ERENUMAB-AOOE, |
||||
| 188 | 26921016 |
GB |
45 | |
Haematochezia, Rash pruritic, Pyrexia, Fatigue, Eczema, Wrong technique in product usage process, Drug dose omission by device, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 189 | 26921034 |
US |
59 | 2 |
Injection site pain, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 190 | 26921064 |
EU |
2 | |
Drug delivery system malfunction, Drug dose omission by device, |
||||
PEGINTERFERON BETA-1A, |
||||
| 191 | 26921244 |
US |
82 | 2 |
Device difficult to use, Drug dose omission by device, Injection site haemorrhage, Product communication issue, |
||||
EVOLOCUMAB, |
||||
| 192 | 26909682 |
US |
1 | |
Drug dose omission by device, Product use complaint, Device failure, Device malfunction, No adverse event, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 193 | 26910121 |
US |
79 | 2 |
Knee arthroplasty, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 194 | 26910359 |
US |
60 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
LEVALBUTEROL TARTRATE, MONTELUKAST SODIUM, MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 195 | 26911320 |
US |
||
Panic reaction, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 196 | 26911422 |
US |
79 | |
Needle issue, Drug dose omission by device, No adverse event, |
||||
TIOTROPIUM BROMIDE, |
||||
| 197 | 26911588 |
US |
78 | 2 |
Incorrect disposal of product, Drug dose omission by device, Product preparation issue, Injection site indentation, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 198 | 26911619 |
US |
74 | |
Drug dose omission by device, Device leakage, No adverse event, |
||||
PREDNISOLONE ACETATE, |
||||
| 199 | 26912363 |
GB |
14 | 2 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 200 | 26912505 |
US |
2 | |
Injection site scar, Nervousness, Device difficult to use, Drug dose omission by device, Product communication issue, |
||||
EVOLOCUMAB, |
||||
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2026-07-30